K233708
- 510(k) number
- K233708
- Device name
- NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
- Applicant
- Synaptic Medical Corporation CA · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2024-02-16
- Date received
- 2023-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233708.pdf
Official FDA record: K233708
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.